Biopsy devices for fine needle aspiration are well known to those skilled in the art. Such devices are useful for obtaining cytologic specimens for examination to confirm the diagnosis of suspected cancers. Generally, such devices are useful in sampling tissue from the breast, the head and neck, lymph nodes, and some gynecologic cancers. Other applications include lung, prostate, and other soft tissue tumor biopsies.
Generally, such biopsy instruments extract samples of tissue through a small needle usually in the range of 25-20 gauge. A vacuum force is usually applied by a standard syringe attached to the needle, while the needle is passed several times in the tissue. A column of cells is then accumulated in the hollow channel of the needle as the needle is passed multiple times into the tumor mass. This procedure can be performed with a syringe alone or in a syringe holding device.
Such syringe holding devices have been in use for at least two decades. A typical device used to perform this technique is disclosed in U.S. Pat. No. 3,819,091, issued to Anders K. Y. Hollander of Boras, Sweden the teachings of which are incorporated herein by reference. Another such device incorporating a syringe holder is disclosed in U.S. Pat. No. 2,472,116, issued to Hyla F. Maynes, the teachings of which are likewise incorporated herein by reference. A still further device which deals with an adjustable aspirating syringe is disclosed in U.S. Pat. No. 2,863,452, issued to Leighten Ogle, and incorporated herein by reference. These devices were primarily issued as syringe holders and were generally not used for fine needle aspiration cytology except for the device designed by Hollander which was specifically designed for aspiration cytology. The device designed by Hollander has a capability of being usable with one hand and further has a capability of utilizing disposable syringes and needle.
The advantages provided by the Hollander device are that it is economical, can be used with one hand, and can provide excellent cytology specimen when used correctly. However, disadvantages also exist with the Hollander device in that the user's hand must be placed behind the piston of the syringe, thereby requiring a distance of approximately 71/2 inches to 81/2 inches from the user's hand to the tissue to be biopsied. This distance is substantial and makes for difficult needle placement, which can thus lead to an inaccuracy in diagnosis. Additionally, the Hollander device makes no provision for locking the device in a specific position so that a constant amount of suction may be applied. Furthermore, such device produces tension in the hand operating the device which can lead to inaccuracy in obtaining fine needle aspiration specimens.
Accordingly, there exists a substantial need in the art to provide an improved fine needle aspiration cytology device that will place the user's hand closer to the patient (i.e., the tissue to be sampled), and also to provide an aspiration cytology device having means for locking the device in a position to provide a fixed amount of suction. Additionally, there is needed an aspiration device wherein the hand is placed in a natural position of function as well as a device having a stable platform for retaining the syringe. These improvements would be particularly desirable when sampling in confined spaces with compact anatomy, such as tumors of the head and neck where a misplaced needle might lead to a complication.